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510(k) K981698

ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) by Chiron Corp. — Product Code MOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1998
Date Received
May 14, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Immunological, Antigen, Tumor
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances by Chiron Corp.

  • K980190 — ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) (March 6, 1998)

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